Analytical Sciences & Technology*
- Boston, MA, United States
Rate of Pay: $156000.00 - $234000.00
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Job details
- Pay
- Rate of Pay: $156000.00 - $234000.00
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- Posting language
- English
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Original job description
*Full job title: Analytical Sciences & Technology Associate Director
Duties:
- Will lead, coordinate, monitor, and collaborate cross-functionally to develop analytical CMC strategies while also providing tactical direction for the execution of the analytical project plan.
- Will communicate and execute the analytical strategy and will involve routine interaction with senior management.
- Will act as the Analytical Product Lead (APL) and have primary responsibility for overseeing programs through the late-stage drug development lifecycle, Marketing Authorization/Biologics Licensure application (MAA/BLA), and Life Cycle management.
May telecommute up to 40%.
Requirements:
Employer will accept a Masters degree, or related field, in Protein Chemistry, Analytical Chemistry, or a related field and 10 years of experience in the job offered or in an Analytical Sciences & Technology Associate Director-related occupation. Alternatively, employer will accept a Ph.D. degree in Protein Chemistry, Analytical Chemistry, or a related field and 7 years of experience in the job offered or in an Analytical Sciences & Technology Associate Director-related occupation.
Position requires demonstrable experience in the following:
- Must have experience with cell and gene therapy or biologics CMC development (CQAs, specifications, comparability) from late-stage development to commercialization.
- Demonstrate an in-depth understanding of analytical techniques used for cell and gene therapy products and knowledge of the cGMPs, USP/ICH, and regulatory guidance for commercial-stage products.
- Demonstrated technical and regulatory writing skills. Must have direct experience with authoring eCTD Module 3 sections of commercial regulatory submissions (MAA/BLA and PASs) and responding to health authority queries.
- Experience with JMP statistical software required, specifically Distribution, Y by X, and Graph Builder platforms.
Rate of Pay: $156000.00 - $234000.00
CONTACT: Send Resume to futuretalent@vrtx.com. Reference 12140.969. EOE.